Methods and devices for controlling heart valves and orifices

Abstract

Heart valve control devices, system, and methods for the same for the treatment or control of diseased or injured heart valves. The heart valve control devices comprise a frame secured to a portion of a heart having a diseased or injured heart valve. The frame includes one or more artificial polymer actuators extending toward and coupled to a portion of the diseased or injured heart valve. A controller activates the polymer to move it into a contracted state, which causes the heart valve to open and allows blood to flow through it.

Description

Non-Provisional Patent ApplicationMethods and Devices For Controlling Heart Valves And OrificesFIELD

[0001] The present invention relates to methods and devices for controlling heart valves and other orifices in humans, animals, and other life-imitating technologies. The methods and devices of the present invention are directed to artificial electro-actuating fibers and devices for controlling operation and movement of one or more heart valves and other orifices.BACKGROUND

[0002] The heart and its valves are crucial components of the cardiovascular system, regulating the proper flow of blood within the heart by opening and closing with each heartbeat. The human heart consists of four valves: the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. Each of the valves operate to ensure that blood flows in the correct direction through the heart, preventing a backflow of the blood, and maintaining efficient circulation throughout the entire vasculature system of the body. Structurally, heart valves are composed of thin flaps of tissue called leaflets or cusps. The leaflets or cusps are supported by fibrous tissue rings known as annuli that encircles each of the valves. The coordinated movement of these component structures allows for efficient and timed pumping of the blood through the heart chambers.

[0003] Like most organs and structures within the human body, the function of the heart valves can be impacted by injury and disease. The diseases encompass a range of conditions that can interfere with the normal functioning of these vital heart structures. Common diseases affecting heart valves include Aortic Stenosis, which occurs when theaortic valve narrows, obstructing blood flow from the left ventricle to the aorta. Individuals with Aortic Stenosis typically have symptoms such as chest pain, shortness of breath, and fainting.

[0004] Another condition, Mitral Valve Prolapse, occurs with the flaps or cusps of the mitral valve bulging backward into the left atrium during heart contractions. While often asymptomatic, the condition can lead to complications such as mitral valve regurgitation. Mitral Valve Regurgitation occurs when the mitral valve fails to close properly, thereby allowing blood to leak backward into the left atrium during ventricular contractions. Individuals with Mitral Valve Regurgitation typically have symptoms such as fatigue, shortness of breath, and heart palpitations.

[0005] Another heart valve condition includes Tricuspid Valve Regurgitation, which involves a leakage of blood backward through the tricuspid valve into the right atrium during ventricular contractions. Tricuspid Valve Regurgitation can result from various causes, including structural abnormalities, infections, and heart failure.

[0006] Yet another heart valve condition includes Pulmonary Valve Stenosis, which is characterized by a narrowing of the pulmonary valve. The narrowing of the pulmonary valve impedes blood flow from the right ventricle to the pulmonary artery. Individuals with Pulmonary Valve Stenosis often have symptoms of chest pain, fatigue, and cyanosis (a bluish discoloration of the skin).

[0007] Infection of the heart tissue or Infective Endocarditis can also negatively impact the function of the heart valves. Infective Endocarditis, or an infection of the inner lining of the heart, can cause an infection or inflammation of one or more of the heart valves. The infection can lead to damage or destruction of the heart valves, resulting in valve dysfunction and potentially life-threatening complications.

[0008] The above conditions can result from congenital defects, infections, degenerative changes due to aging, or other underlying health issues. If left untreated, heart valve diseases can lead to serious complications such as heart failure, arrhythmias, and even death.

[0009] Advancements in medical technology have revolutionized the treatment of diseased or failing heart valves, offering patients a range of options to improve heart function and their quality of life. The first innovation was the aortic valve replacement, which entailed a surgeon opening a patient’ s chest, performing a sternotomy, and opening the patient’ s heart to replace their aortic valve. The traditional aortic valve replacement was a major surgery that required extensive recovery time.

[0010] More modern techniques were developed to overcome the shortcomings of the traditional aortic valve replacement surgery. One such innovation is the transcatheter aortic valve replacement (TAVR), which is a minimally invasive procedure that allows for the replacement of a diseased aortic valve without open-heart surgery. During TAVR, a collapsible replacement valve is guided through a catheter and implanted within the native valve, restoring proper function and blood flow. This approach is particularly beneficial for high-risk patients who may not be suitable candidates for traditional surgical valve replacement.

[0011] Similarly, transcatheter mitral valve repair (TMVR) has emerged as a less invasive alternative for treating mitral valve regurgitation. Using catheter-based techniques, surgeons are able to deploy devices to repair the mitral valve. These procedures offer significant advantages over traditional open-heart surgery, including shorter recovery times, reduced risk of complications, and improved outcomes for patients with complex medical conditions.

[0012] As technology continues to advance, the field of heart valve intervention is poised to further expand, providing new hope for patients with valvular heart disease.

[0013] Among all transplantation surgeries, heart transplantation is amongst the major surgical procedures of organ replacement. There are approximately 5,000 heart transplantations performed each year worldwide. Furthermore, there are 250,000 deaths reported annually in the United States with 9,00,000 hospitalizations due to heart failure. In contrast, it has been estimated that over 60,000 patients in the United States can benefit from heart transplantation. However, the critical shortage of this organ has led many researchers to explore ways to assist heart patients, at least temporarily, until a transplantation takes place.

[0014] There has been a need for miniaturization and technical advances in material science to develop a more modern approach that addresses the failings of conventional cardiac disease treatments.

[0015] There is a need for electrically active contractile polymer-based muscle replicants that can be coupled to the existing valvular structure.

[0016] There is a need for electrically active contractile polymer-based muscle replicants that can replicate the natural operation of the valvular structure.

[0017] There is also a need for electrically active contractile polymer-based muscle replicant systems that can be formed into an artificial muscle that can be implanted into humans and animals.

[0018] There is a need for electrically active contractile polymer-based muscle replicants that can be combined with and extend between non-native tissue or a medical device and native cardiac tissue.

[0019] There is a need for electrically active contractile polymer-based muscle replicants to be used in artificial heart muscle (AHM) or tendons as an effective treatment for diseased or defective cardiac valves.

[0020] There is a need for novel electrically active contractile polymer-based muscle replicants that form an apparatus, device, system or part of a method of treatment that may be adapted to various and unique anatomy so that therapy may be properly applied to treat various conditions.

[0021] There is a need for novel electrically active contractile polymer-based muscle replicants that form an apparatus, device, system or part of a method of treatment that may be adapted to any part of a patient’ s circulatory system, including but not limited to arteries and veins to treat various circulatory disorders.

[0022] There is a need for novel electrically active contractile polymer-based muscle replicants that form an apparatus, device, system or part of a method of treatment that may be adapted to a patient’ s bladder to treat various urinary or excretory disorders.

[0023] The object of the present invention is to address one or more of the above problems, while maintaining the advantages of prior art.SUMMARY OF THE INVENTION

[0024] Artificial muscle or tendon device and method of manufacturing the same for the treatment or control of an organ such as the heart. The artificial muscle or tendon device comprises artificial actuators or fibers that can work together to form the artificial muscle or tendon. The artificial fibers are electrically active and more particularly electrothermally active contractile polymers capable of various actions or characteristics, including increased contractile forces and contractile directional control. The artificialactuators or control can be knitted, weaved, or otherwise configurable into unique patterns, shapes, and configurations to create unique artificial muscles, ligaments, actuators, and controls that can be shaped or configured into implantable devices.

[0025] Additional features and embodiments will be apparent from the attached patent claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The invention will be described in more detail in the detailed description below with reference to the appended drawings, in which:100271 Tig. 1A is a perspective partial cross section view of human heart illustrating the different heart valves treatable by the present invention;

[0028] Fig. IB is a perspective partial cross section view of human heart with various example embodiments of the present invention coupled to the different heart valves;

[0029] Fig. 2 is a perspective partial cross section view of human heart showing placement of the present invention to a heart valve;

[0030] Fig. 3 is a perspective partial cross section view of human heart showing the present invention in place about a heart valve;

[0031] Fig. 4A is a front view illustrating a power supply and controller of the present invention;

[0032] Fig. 4B is a top view illustrating an anchor member attached to and extending away from a frame of the device of the present invention.

[0033] Fig. 4C is a front view illustrating a sleeve or pouch embodiment of the presentinvention.

[0034] Fig. 5A is a top view that illustrates the heart valve control device of the present invention implanted on a tricuspid valve in a closed-state;

[0035] Fig. 5B is a top view that illustrates the heart valve control device of the present invention implanted on a tricuspid valve in an opened-state;

[0036] Fig. 6A is a top view that illustrates the heart valve control device of the present invention implanted on a bicuspid valve in a closed-state;

[0037] Fig. 6B is a top view that illustrates the heart valve control device of the present invention implanted on a bicuspid valve in an opened-state;

[0038] Fig. 7 is a cross-section view of an active contractile polymer of the present invention coupled to a portion of a frame of the invention and extending along a portion of a heart valve; and

[0039] Fig. 8 is a top view of the heart valve control device of the present invention having active contractile polymers arranged in a weave or mesh pattern.

[0040] Fig. 9 is a schematic diagram of the operation of the heart valve control device of the present invention.DETAILED DESCRIPTION

[0041] The detailed description and specific examples contained herein, while indicating example embodiments of the apparatus, systems and methods, are intended only for the purpose of illustration and are not intended to limit the scope or breadth of the invention. Features, aspects, and advantages of the present invention are discussed in the followingdescription, claims, and the accompanying figures. The figures are for illustration purposes only and are not drawn to scale. Identical reference numbers are used throughout the figures and description to indicate same or similar parts.

[0042] The present invention, illustrated in Figs. 1-9, is directed to novel medical devices manufactured from medical grade materials, including artificial muscle fibers or tendons that comprise electrothermally active contractile polymers. An example of electrothermally active contractile polymers or actuators, were originally described in US Patent Application No. 17 / 943, 122, filed on September 12, 2022, the entirety of which is incorporated herein by reference. The electrothermally active contractile polymers or actuators are made having various physical characteristics that, when incorporated into the device, system, and method of the present invention, can be implanted to aid a patient suffering from one or more heart diseases affecting the heart, and more particularly the heart valves.

[0043] The present invention includes a plurality of configurations or embodiments that are designed to aid in the opening or closing of one or more compromised heart valves. As illustrated in Fig. 1A, a Heart (A) includes the Tricuspid Valve (B), Pulmonary Valve (C), Mitral Valve (D), and the Aortic Valve €. Each of these heart valves play a vital role in ensuring blood flows properly through the heart.

[0044] Each heart valve has specific anatomical features that the present invention can selectively manipulate to ensure proper function. These features include an Annulus (F), which is a ring of fibrous tissue surrounding the valve's opening. Connected to the Annulus(F) are Leaflets or Cusps (G), which are flap-like structures that extend into the opening and can open and close to regulate blood flow through the heart. The Leaflets or Cusps(G) allow blood to flow in one direction and prevent backflow. The number of Leaflets(G) varies depending on the valve: the Mitral and Tricuspid Valves each have two leaflets, while the Aortic and Pulmonary Valves each have three leaflets.

[0045] Heart A also contains the Chordae Tendineae (H), which are tough, fibrous cords connecting the Leaflets (G) to the Papillary Muscles (I). These muscles are small and are situated within the tissue of Heart (A). The Chordae Tendineae (H) play a crucial role in maintaining the correct position of the Leaflets (G) by preventing them from prolapsing (bulging backward) into the atria during ventricular contraction. Additionally, the Papillary Muscles (I) help stabilize the Leaflets G throughout the cardiac cycle.

[0046] Turning to Fig. IB, various embodiments of heart valve control devices 10 are illustrated. In some example embodiments, heart valve control device 10, comprises a support or frame 20 that is configured to be coupled to a portion of the Heart (A). Frame 20 can have different shapes and configurations. In one embodiment, as particularly illustrated in Figs. 2 and 3, frame 20 has an annular or ring shape with one or more openings 22 extending through it. The openings 22 extending through frame 20 permit an anatomical structure such as Chordae Tendinea (H) to extend through them without frame 20 impeding their natural operation. Referring to Fig. 4A, frame 20 may comprise an upper surface 21a, a lower surface 21b, an inner surface 21c, and an outer surface 21d.

[0047] As illustrated in the example embodiment of Fig. 2, frame 20 can be manufactured with one or more frame segments 24a and 24b operatively coupled together by a fastening or hinging mechanism 26. The fastening or hinging mechanism 26 has a configuration that permits segments 24a and 24b to at least temporarily separate, move, or adjust away from, with respect to one another, to enable a surgeon to place frame 20 around an anatomical structure such as the Chordae Tendinea (H). In one example embodiment, the hinging mechanism 26 comprises a spring having opposed ends attached to a portion of framesegments 24a and 24b. In another example embodiment, the hinging mechanism 26 comprises a generally curved bar or panel having opposed ends attached to a portion of frame segments 24a and 24b. In this example embodiment, the curved bar or panel may have generally bendable or pliable properties. The hinging mechanism 26 may comprise any shape or configuration capable of having opposed ends that are either permanently or temporarily attached to a portion of frame segments 24a and 24b.

[0048] In another example embodiment, frame 20 includes one or more anchor members or tabs 28, that are used by a surgeon to fasten frame 20 to heart tissue. Frame 20 can be manufactured with anchor members, such as tabs 28, being coupled to or integral with a portion of frame 20. Tabs 28 can extend beyond an outer periphery of any of the surfaces (e.g., 21a-21d) of frame 20 depending upon how device 10 is being attached and used by a surgeon. Anchor members 28 can be manufactured in different shapes and configurations. For example, as illustrated in Fig. 4B, anchor members 28 can have an annular or ring shape radiating outwardly from frame 20. Anchor members 28 can also comprise individual spaced apart generally planar structures or panels that may be the same or a different material than frame 20. In one example embodiment, anchor members 28 may comprise a biologically compatible mesh or sheet material that is configured to permit tissue ingrowth into it to further secure frame 20 in place.

[0049] As illustrated in Fig. 2, anchor members or tabs 28 can include one or more holes 30 extending through them to permit a surgeon to stitch or otherwise fasten tabs 28 to the heart tissue proximate the heart valve or other cardiac feature to be assisted or controlled by the present invention. In another example embodiment, a biocompatible adhesive or mechanical fastener 31a may be applied between a lower surface 29 of tabs 28 and the heart tissue to secure frame 20 into a desired location. Tabs 28 can also, or alternatively, have other fastening features / structures, including but not limited to hooks, barbs, eyelets,posts, and the like 31b that may extend from lower surface 29.

[0050] As illustrated in Fig. IB, heart valve control device 10 also comprises one or more electrothermally active contractile polymers or actuators (“ACPs”) 40 coupled to a portion of frame 20. In one embodiment, ACPs 40 have a free end 42 that are configured to be secured to a portion of Leaflets G or to another anatomical feature to be controlled. ACPs 40 allow for the tailoring or selective actuation of the heart valves. The selective actuation includes but is not limited to variations in: 1) applied force, 2) direction of applied force, 3) work, 4) heat generation, 5) location of heat dissipation, 6) length of actuation, 7) timing of actuation, and 8) combinations of 1-7 above. The selective actuation enables a more precise control of a function of any anatomical structure, including the heart valves.

[0051] In additional embodiments of the invention, frame 20 and / or ACPs 40 can be placed, positioned, or implanted above or annularly, below or sub-annularly, or lateral to a heart valve. ACPs 40 can be operatively coupled to a portion of frame 20 and extend or radiate outwardly, inwardly, upwardly, or downwardly, from frame 20. ACPs 40 may extend or radiate from frame 20 in an angular fashion, including, but not limited to, between 0 and 180 degrees. ACPs 40, whether operatively coupled to frame 20 or implanted on or in valve leaflet tissue, may be operatively controlled (e.g., contracted or released) either directly (e.g., wired) or wireless (e.g., power source and transmitter) located a distance from the ACPs 40. In one example embodiment, heart valve control device 10 is used in combination with a cardiac device (e.g., pouch or sleeve of US Patent Application No. 17 / 943, 122).100521 In another example embodiment of the invention, frame 20 comprises additional frame structures that are operatively coupled to the annular portion of frame 20. The additional frame structures include rods, arms, or other supportive or operative featuresextending away from frame 20 and configured to support ACPs 40, heart tissue, including valve leaflets. In yet another example embodiment, the heart valve may comprise partly of a valve skeleton frame 20 or completely of ACPs 40 having a coating as described herein or within US Patent Application No. 17 / 943,122.

[0053] Heart valve control device 10 may include a power supply 32 and a controller 34 that are in operative communication with ACPs 40, frame 20, or both. As illustrated in Fig. 4A, power supply 32 and controller 34 can be positioned in a cavity or interior compartment 36 formed in a portion of frame 20. Controller 34 is operatively coupled to or in communication with each of ACPs 40 to control their actuation, contraction, or operation thereof. Power supply 32 and / or controller 34 can also be contained within a separate housing that can be implanted into, or secured external to, a patient.

[0054] Charging of power supply 32 and control of controller 34 can be done either by direct wire connections or wirelessly through any wireless communication now known or available in the future, including but not limited to Bluetooth®, Wi-Fi, Z-Wave, Cellular (e.g., 3G, 4G, 5G, LTE), NFC, RFID, and the like. While Figs. 4A and 6A illustrate controller 34 being connected to ACPs 40 by a wire, it can also use wireless technology to allow charging and control of the ACPs 40.

[0055] Example configurations of the present invention positioned on a heart valve are illustrated in Figs. 5A-6B. In one embodiment, as illustrated in Figs. 5A and 6A (i.e., valve in a closed position) and Figs. 5B and 6B (i.e., valve in an open position), frame 20 is positioned on or about a valve. The illustrated example embodiments particularly demonstrate the ACPs 40 acting as new artificial muscle fibers capable of more versatile and selective contraction or operation.

[0056] In one example embodiment of the present invention, the heart valve control device10 includes a remote or wireless controller or charger 33 that is able to wirelessly charge the heart valve control device 10 or its power supply 32. The wireless charger 33 can take any form including but not limited to a puck, mat, or a pad that can be placed in proximity to the heart valve control device 10. A belt or other securing device 39 can be used to removably secure the wireless charger in place against a patient’ s skin. The charging process can use any currently known or yet to be invented charging technology such as induction, radio, and resonance.

[0057] As particularly illustrated in Figs. 5A and 5B, for Tricuspid Valves, ACPs 40 are coupled to a portion of frame 20 with free end 42 extending or radiating toward an end of Leaflets (G). Free end 42 is coupled to the end, or another portion, of Leaflets (G). In this configuration, when an ACP 40 is activated (i.e., contracted) it moves Leaflet (G)from a closed position (see Fig. 5A) toward an opened-position (see Fig. 5B). As it is opened blood is able to flow through the heart valve. Once activation of the ACP 40 is stopped it moves from the opened-position toward the closed-positioned. Once ACP 40 is in the closed-position it blocks the flow of blood and prevents it from backflowing in the heart.

[0058] Depending upon the damage or defect in Leaflet (G), location or placement of ACPs 40 on frame 20 or Leaflets (G) may be altered or adjusted so they are placed on or as close as possible to the anatomical defect. In this way, heart valve control device 10 is configured to most accurately compensate for the anatomical defect and to allow the defective heart valve to operate as closely as possible to a non-defective heart valve.

[0059] An example embodiment of the present invention positioned to aid operation of a Bicuspid Aortic Valve is illustrated in Figs. 6A and 6B. In this configuration, heart valve control devices 10 have their ACPs 40 oriented from frame 20 toward a central opening 48 of the valve. In this configuration ACPs 40 can move from the closed-position (see Fig.6A) toward the opened-position (see Fig. 6B) when they are activated by controller 34 and power supply 32.

[0060] Referring to Fig. 7, ACPs 40 can be manufactured with a substrate coating 50 that comprises any material capable of receiving and / or supporting the ACPs 40. A medical grade silicone material capable of being implanted can be used as the substrate coating 50. Substrate coating 50 can be manufactured in various shapes and configurations. Referring to Fig. IB, heart valve control devices 10, with or without substrate coating 50, can be configured as a sleeve or plug having generally open opposed ends, which allow the devices 10 to be surgically positioned around or about Leaflets (G). As particularly illustrated in Fig. 7, ACPs 40 can be configured as individual strands connected or adhered to a portion of a Leaflet (G). ACPs 40 of the present invention can also be manufactured in a weave or textile configuration to impart different force or control characteristics to different anatomical features.

[0061] Referring to Figs. 8, heart valve control device 10 can also be configured in the form of a patch 60 of woven or knitted ACPs 40. Patch 60 can be coupled to a portion of frame 20 or it may be implanted by itself without frame 20. Patch 60 can be manufactured with or without substrate coating 50.

[0062] Patch 60 can be in operative communication with power supply 32 and controller 34, which can control simple or complex actuations of ACPs 40. Complex actuations of ACPs 40 control patch 60 to apply a particular force, speed, and timing to each individual fiber, whereby Leaflets (G) function more naturally. Patch 60 permits control of valves and Leaflets (G) in more than one axis to ensure proper valve operation. Heart valve control device 10 can also be manufactured in a number of other configurations, including but not limited to a pouch, funnel, plug and any other configuration that is able to becoupled to, implanted within, or secured in or to a portion of the heart.

[0063] As mentioned above, the ACPs 40 can be knitted into various configurations and patterns. For example, ACPs 40 can be formed into a mesh configuration having various angular orientations with respect to one another. In one embodiment, ACPs 40 are fabricated with specific individual ACPs 40 oriented in one direction having a greater contractile force than ACPs 40 oriented in angular direction. In this configuration, heart valve control device 10 is able to provide more tailored or custom implants and treatments for personalized therapies.

[0064] Generally, each ACP 40 of heart valve control devices 10 can move from a first position (e.g., non-contracted state) to a second position (e.g., contracted state), such as in a contraction or contractile movement. ACPs 40 can also move back from the second position to the first position to complete a full cycle. The full cycle from non-contracted or extended state to contracted state of ACPs 40, in conjunction with controller 34, enables the heart valves to operate without implanting an artificial heart valve.

[0065] In another example embodiment, as illustrated in Fig. 7, heart valve control devices 10 also comprise one or more sensors or other sensing devices 62 that are configured to control ACPs 40 upon detecting a signal from the heart. In some embodiments, sensors 62 can sense or detect a signal (e.g., papillary muscle contraction) that would normally activate, or control Chordae Tendineae (H) connected to the Leaflets (G). Sensors 62, upon detecting a signal, communicate with controller 34 to activate ACPs 40. Once activated, ACPs 40 move from their non-contracted state to their contracted state. Their contraction thereby causes the Leaflets (G) to open and blood to flow through the valve. Once sensors 62 no longer detect a signal they communicate with controller 34 that ceases activating ACPs 40. Once ACPs 40 no longer are being contracted by controller 34 theyare allowed to expand or lengthen into their non-contracted state. In the non-contracted state, ACPs 40 force or allow Leaflets (G) to move into a closed position, thereby blocking the flow of blood through the valve. In another example embodiment of the invention, other ACPs 40 can be used to position or move the Leaflets (G) from their opened-position to their closed-state. Controller 34 can be used to activate or control different ACPs 40 or ACP zones to complete a full open-close cycle.

[0066] The ACPs 40 of the present invention are thermally driven making them great candidates for heart valve control devices 10. ACPs 40 of the present invention utilize electrothermal energy as a clean source of energy for their operation. In some embodiments of the present invention, ACPs 40 are manufactured with a silver coating to improve their conductivity.

[0067] ACPs 40 of the present invention can also be manufactured with an insulating material such as silicone. The silicone coating provides electrical insulation between adjacent ACPs 40 preventing errant ACPs 40 from being activated. Additionally, a silicone elastomer identical to or different from the silicone coating on ACPs can be used to interconnect different ACPs 40 in the formation of an artificial muscle or group of tendons. While not required, ideally the interconnecting material will be a soft, stretchy, and flexible material akin to human flesh, muscle, or tendon. This allows ACPs 40 to move in a more natural way closer to the movement of human tissue and organs.

[0068] Referring to Fig. 9, the application of heart valve control device 10 itself is carried out by electrical impulses that may be either artificially provided (e.g., battery) or naturally produced (e.g., heart muscle contraction), or a combination thereof. In the area of the pulmonary and aortic valve, an external cuff may also be used to constrict insufficient valves from the outside, thereby causing sufficient valve closure.

[0069] In yet another example embodiment of the present invention, intravalvular application of the present invention in the area of the tricuspid and mitral valves may comprise a "smart clip" or “smart frame” 20. The smart clip provides continuous or ongoing treatment throughout the different stages of the patient’ s heart disease. For example, in the case of a two-stage narrowing of the valve, for example after 1-2 years after the initial opcration / implantation of device 10, smart clip or frame 20 is able to receive a signal, whereby a further external contraction of the smart frame 20 or any of its components or features, any or all of ACPs 40 by Bluetooth or electrically conductive leads to improved valve closure in the case of secondary valve pathologies, which may reoccur after the initial operation.

[0070] Heart Valve control device 10 also comprises a controller 34 configured to run one or more computer programs or algorithms 35 stored in memory 37 in operative communication with the controller. The algorithms 35 are synchronized with the cardiac cycle. Controller 34 and the computer programs 35 are capable of continuously monitoring cardiac cycles and automatically adjust any parts, components, or features of heart valve control device 10. Controller 34 is also configured to communicate with healthcare staff and other devices and systems that may be implanted into, worn by, or used by the patient or healthcare staff.

[0071] The present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof, and it is, therefore, desired that the present embodiment be considered in all respects as illustrative and not restrictive. Similarly, the above-described methods and techniques for forming the present invention are illustrative processes and arc not intended to limit the methods of manufacturing / forming the present invention to those specifically defined herein.

Claims

CLAIMSWhat is claimed is:1 . An implant configured to be implanted in a heart of a patient to monitor a rhythm of the heart and to control one or more heart valves having two or more flaps or leaflets, the implant comprising: a frame having a lower surface configured to be positioned adjacent to the heart valve, and an inner surface that is configured to face toward the heart valve; one or more electrothermally activated polymers having a first end coupled to the inner surface of the frame and a second end configured to be attached to the flap of the heart valve, wherein the one or more electrothermally activated polymers have an extended configuration and a contracted configuration; a power supply in operative communication with the one or more electrothermally activated polymers, wherein application of the power supply moves the one or more electrothermally activated polymers from the extended configuration toward the contracted configuration; and a controller in operative communication with the power supply, the controller being configured to control the power supply to time movement of the one or more electrothermally activated polymers between the extended configuration and the contracted configuration with the function of the heart valve.

2. The implant of claim 1, wherein the frame further comprises an interior compartment, the power supply and the controller being housed in the interior compartment and operationally coupled to the one or more electrothermally activated polymers.

3. The implant of claim 1 , further comprising an anchor member coupled to and extending away from a portion of the frame, wherein the anchor member is configuredto attached to the heart valve.

4. The implant of claim 3, wherein the anchor member comprises a tab having one or more holes extending through it to receive a fastener.

5. The implant of claim 3, further comprising one or more barbs extending from the anchor member, the one or more barbs being configured to engage the heart valve.

6. The implant of claim 1 , wherein the one or more electrothermally activated polymers comprise a coil of electro thermo- active material configured to move from the extended configuration toward the contracted configuration when exposed to electricity.

7. The implant of claim 1, wherein the frame is comprised of one or more frame segments coupled together by a hinge.

8. The implant of claim 1, wherein the frame comprises one or more electrothermally activated polymers.

9. The implant of claim 1, wherein the one or more electrothermally activated polymers are arranged as one or more sheets configured to extend over a surface area of the heart valve.

10. The implant of claim 9, wherein the one or more electrothermally activated polymers are arranged having various long axes, wherein each of the one or more electrothermally activated polymers are individually activated to tailor a movement of the one or more sheets.11 . The implant of claim 1 , wherein the one or more electrothermally activated polymers are arranged as a sleeve configured to extend around a portion of the heart valve.

12. The implant of claim 11 , wherein the one or more electrothermally activated polymers are arranged having various long axes, wherein each of the one or more electrothermally activated polymers are individually activated to tailor a movement of the sleeve.

13. The implant of claim 1, further comprising a remote charger configured to charge the power supply.

14. The implant of claim 1, further comprising an algorithm stored in memory in operative communication with the controller, the algorithm being configured to control the activation of the power supply and movement of the one or more electrothermally activated polymers.

15. The implant of 14, further comprising one or more sensors in operative communication with the controller, wherein the sensors are configured to measure the rhythm of the heart, which is sent to the algorithm to control the one or more electrothermally activated polymers.

16. The implant of claim 15, wherein the one or more sensors are configured to detect a change in the rhythm of the heart and to communicate the change to the algorithm, which is configured to initiate the controller to modify the frame or the one or more electrothermally activated polymers.

17. A method of monitoring a rhythm of the heart of a patient and to control one or more heart valves having two or more flaps or leaflets, the method comprising: positioning a frame having a lower surface adjacent to the heart valve, and an inner surface that is configured to face toward the heart valve;activating one or more electrothermally activated polymers having a first end coupled to the inner surface of the frame and a second end attached to the flap of the heart valve, wherein the one or more electrothermally activated polymers move from an extended configuration and a contracted configuration; activating a power supply in operative communication with the one or more electrothermally activated polymers to moves the one or more electrothermally activated polymers from the extended configuration toward the contracted configuration; and providing a controller in operative communication with the power supply to control the activating of the power supply to time movement of the one or more electrothermally activated polymers between the extended configuration and the contracted configuration with the function of the heart valve.

18. The method of claim 17, further comprising storing an algorithm in memory in operative communication with the controller to control the activation of the power supply and movement of the one or more electrothermally activated polymers.

19. The method of 18, further comprising attaching one or more sensors to a heart to measure the rhythm of the heart and to communicate the measured rhythm of the heart to the controller to control the one or more electrothermally activated polymers.

20. The method of claim 19, further comprising the step of detecting a change in rhythm of the heart by the sensor, communicating the change to the algorithm which initiates controller to modify the frame or the one or more sensors.

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